CE marking time

[pseudoazurin]

Hi Everyone,

Does anything know what sort of time are we talking about if we want to get a NEW Class IIb product CE mark? I know it varies for NB and complexity of the device, but I guess with NB still busy dealing with the transition of legacy products to MDR, there may not be a lot of new products coming out or taking longer then expected, but what sort of timing are we talking about, 6, 9 or 12 months from submission to obtain CE marking?

Thx.

 

[Billy Milly]

If you currently do not have a NB, I would lean more towards 2 years. If you find a NB.

This is my estimate, I only have experience up to IIa.

 

[Raisin picker]

New, Class IIb: Better calculate with 18 months. When you find a NB at all. It does also depend on the device type (MDA/MDN codes), since the NB often have limited resources for some types of devices.
Very bad in my experience: Software MDA0315. A lot of software was class I under MDD and is now class IIa/b under MDR. So NBs didn't need many software experts under MDD, hence they are scarce now. I heard of a waiting list of up to one year for the first assessment round (in rare cases).

Just today, I received this list of "coverage of designation codes for notified bodies designated under the Medical Devices Regulation (MDR) and the In Vitro Diagnostic Medical Devices Regulation (IVDR)".

 

[pseudoazurin]

On a similar note, anyone know the timing for UKCA mark for Class IIb product?

 

[Ed Panek]

Our NB is predicting 18-24 (After admin review and acceptance) for CE clearance for our iia.

 

[pseudoazurin]

Sorry, I presume you are referring to CE rather than UKCA, as I added another question at the bottom.